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The study "Interim Estimated Effectiveness of 2025-2026 COVID-19 Vaccines in Adults Using a Test-Negative Design" was published in JAMA Network Open.
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Researchers evaluated the interim effectiveness of the 2025-2026 coronavirus disease 2019 (COVID-19) vaccines in preventing COVID-19-associated emergency department, urgent care, and hospital encounters among immunocompetent adults in the United States.
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COVID-19 was associated with an estimated 390,000 to 550,000 hospitalizations in the United States from October 2024 to September 2025.
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The researchers conducted a case-control study using a test-negative design to evaluate the estimated effectiveness of the 2025-2026 COVID-19 vaccines among immunocompetent adults aged 18 years and older in the United States.
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Data were obtained from the Virtual SARS-CoV-2, Influenza, and Other Respiratory Viruses Network, an electronic health record-based system that included 253 emergency department and urgent care facilities and 179 hospitals across seven states.
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Eligible encounters occurred between September 3, 2025, and December 31, 2025.
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Patients were considered vaccinated if they had received a 2025-2026 COVID-19 vaccine at least 7 days before the encounter.
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The analysis included 85,725 emergency department and urgent care encounters among immunocompetent adults with COVID-19-like illness.
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In the emergency department and urgent care analysis, 3,941 patients positive for SARS-CoV-2 were identified as cases and 81,784 patients with negative molecular test results were classified as controls.
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A total of 9,659 individuals in the emergency department and urgent care analysis had received a COVID-19 vaccine in 2025-2026 before their encounter.
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In the emergency department and urgent care analysis, 5% of cases were vaccinated compared with 12% of controls.
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Of all patients in emergency departments or urgent care facilities during the study period, 60% were between the ages of 18 and 64.
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Of all patients in emergency departments or urgent care facilities during the study period, 60% were female.
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The highest number of emergency department and urgent care encounters occurred during December 2025.
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The estimated effectiveness of the 2025-2026 COVID-19 vaccine against COVID-19-associated emergency department and urgent care encounters among adults aged 18 years and older was 50% (95% confidence interval [CI], 42%-57%).
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The median time since vaccination for adults aged 18 years and older in the emergency department and urgent care analysis was 47 days.
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Among adults aged 65 years and older, vaccine effectiveness against emergency department and urgent care encounters was 48% (95% CI, 37%-56%).
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The median time since vaccination for adults aged 65 years and older in the emergency department and urgent care analysis was 48 days.
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The hospitalization analysis included 26,073 adults admitted with COVID-19-like illness.
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In the hospitalization analysis, 1,022 patients tested positive for SARS-CoV-2 and were classified as cases, while 25,051 tested negative by molecular testing and served as controls.
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A total of 3,140 hospitalized patients had received a 2025-2026 vaccine dose before admission.
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In the hospitalization analysis, vaccinated individuals accounted for 6% of cases and 12% of controls.
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Among hospitalizations, 67% occurred among patients 65 years and older.
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Women accounted for 54% of hospitalizations in the study.
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More than two-thirds of hospitalizations occurred among non-Hispanic White patients.
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December 2025 recorded the largest number of hospitalizations during the study period.
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In adults 18 years old and over, the estimated effectiveness of the COVID-19 vaccination against COVID-19-associated hospitalization was 55% (95% CI, 41%-66%) among people vaccinated at least 7 days earlier.
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The median time since vaccination for adults 18 years and older in the hospitalization analysis was 46 days.
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For adults 65 years and over, the vaccine was estimated to provide 53% effectiveness (95% CI, 37%-65%) against hospitalization.
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The median time since vaccination for adults 65 years and older in the hospitalization analysis was 46 days.
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The analysis did not directly account for prior SARS-CoV-2 infection or prior COVID-19 vaccine doses.
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The study did not assess protection over longer periods, against critical illness or death, in children, or in immunocompromised adults.
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